FDA-Device2025-12-17Class IIMISBRANDING
BD InLay Optima Ureteral Stent Kit recalled for labeling mismatch
What this means
C.R. Bard Inc. has recalled certain BD InLay Optima Ureteral Stent Kits (8 Fr. x 26 cm, REF 78826, Lot# NGJU4328) because the actual stent size may not match what the label says. This labeling error could lead to incorrect stent selection during medical procedures.
- If you have this stent kit (Lot# NGJU4328), verify the actual stent dimensions match the package label before use.
- Do not use the stent if you cannot confirm the size matches the labeled dimensions.
- Contact your supplier or C.R. Bard Inc. for instructions on returning or replacing affected units.
The agency's original wording
Hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
Affected count
116 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0908-2026Want us to check the next one for you?
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